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Clinical trials for Food and Drug Administration

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44393   clinical trials with a EudraCT protocol, of which   7405   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    131 result(s) found for: Food and Drug Administration. Displaying page 1 of 7.
    1  2  3  4  5  6  7  Next»
    EudraCT Number: 2014-004766-15 Sponsor Protocol Number: MK-0518B-254 Start Date*: 2015-05-04
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: MK-518B Food Effect Study
    Medical condition: N/A
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-005492-13 Sponsor Protocol Number: TMC207TBC1002 Start Date*: 2013-03-26
    Sponsor Name:Janssen infectious diseases BVBA
    Full Title: A Phase I, open-label, randomized, 3-way crossover study in 3 Panels of healthy, adult subjects to assess the relative bioavailability of TMC207 following single-dose administration of two pediatri...
    Medical condition: Multi-drug resistant tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-000258-76 Sponsor Protocol Number: 2019-PRO/CAP/006-BE Start Date*: 2019-11-21
    Sponsor Name:Proveca Ltd.
    Full Title: A single-dose, open-label, randomised, three-way crossover study to assess the comparative bioavailability of Captopril oral solution 5 mg/mL relative to captopril tablets and to investigate the ef...
    Medical condition: Captopril 5 mg/mL oral solution is a new oral pharmaceutical formulation intended for the treatment of congestive heart failure in male and female paediatric patients from birth to 18 years.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003805-23 Sponsor Protocol Number: A8081069 Start Date*: 2021-08-12
    Sponsor Name:Pfizer, Inc.
    Full Title: A PHASE 1, OPEN LABEL, CROSSOVER STUDY TO EVALUATE PALATABILITY AND RELATIVE BIOAVAILABILITY OF TWO PEDIATRIC MICROSPHERE FORMULATIONS OF CRIZOTINIB IN HEALTHY PARTICIPANTS
    Medical condition: This study was conducted in healthy subjects and it is required that all trial participants don’t have any medical condition.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-004044-37 Sponsor Protocol Number: GS-US-342-1142 Start Date*: 2017-12-07
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 1 Relative Bioavailability and Food Effect Study of a Pediatric Oral Granule Formulation of SOF/VEL in Healthy Adult Subjects.
    Medical condition: Chronic Hepatitis C virus infection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-006235-33 Sponsor Protocol Number: 738/02/2011 Start Date*: 2012-03-30
    Sponsor Name:MDM S.P.A.
    Full Title: Sensory Motor Neuropathies of the sciatic nerve: a comparative evaluation of dextrorotatory enantiomer of thioctic acid and acetyl-L-carnitine.
    Medical condition: sensitive motor sciatic neuropathy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10066699 Acute polyneuropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001964-13 Sponsor Protocol Number: HAF85 Start Date*: 2016-05-06
    Sponsor Name:Sanofi Pasteur Korea Ltd
    Full Title: Regulatory Post-Marketing Surveillance (PMS) Study for AVAXIM 160U (Hepatitis A Vaccine)
    Medical condition: Hepatitis A
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-003428-61 Sponsor Protocol Number: GS-US-380-4449 Start Date*: 2018-04-06
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching from an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) ES (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001446-24 Sponsor Protocol Number: 178-CL-201 Start Date*: 2014-10-09
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Phase 1, Single Dose, 4-Period Crossover Study to Assess the Bioavailability of an Mirabegron Oral Suspension Relative to the Mirabegron Prolonged Release Tablet and to Assess the Effect of Food ...
    Medical condition: No medical indication will be investigated as only healthy subjects will be included.
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004857 10059617 Overactive bladder LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-003226-25 Sponsor Protocol Number: Abifood01 Start Date*: 2013-07-12
    Sponsor Name:Fundacion Publica Andaluza para la Gestion de la Investigacion en Salud de Sevilla
    Full Title: Phase I, randomized, open design trial to evaluate the effect of food (fasting, fat meal and standard meal) on the pharmacokinetics of abiraterone acetate at reduced doses, compared with convention...
    Medical condition: metastatic prostatic cancer after castration-resistant progression to docetaxel
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004864 10036947 Prostatic cancer metastatic LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-004134-15 Sponsor Protocol Number: 2013-OX Start Date*: 2014-07-15
    Sponsor Name:Dutch Growth Research Foundation
    Full Title: Intranasal administration of oxytocin in children and young adults with Prader-Willi Syndrome. A randomized, double-blind, placebo-controlled trial. Effects on satiety and food intake, and social b...
    Medical condition: Prader-Willi syndrome
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10036476 Prader-Willi syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003441-13 Sponsor Protocol Number: D8480C00021 Start Date*: 2007-07-30
    Sponsor Name:AstraZeneca AB
    Full Title: A Two-part, Open-label, Multi-centre, Phase II Study in Patients with Advanced Solid Tumours, Consisting of a Randomised 2-period Crossover Protocol to Determine the Effect of Food upon the Pharmac...
    Medical condition: Patients with advanced solid tumour
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-001876-67 Sponsor Protocol Number: B2061030 Start Date*: 2016-07-27
    Sponsor Name:Pfizer Inc.
    Full Title: A 6-Month Open-Label, Multicenter, Flexible-Dose Extension Study to the B2061032 Study to Evaluate the Safety, Tolerability and Efficacy of Desvenlafaxine Succinate Sustained-Release (DVS SR) in th...
    Medical condition: Major Depressive Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-002064-34 Sponsor Protocol Number: B2061031 Start Date*: 2016-04-11
    Sponsor Name:Pfizer Inc.
    Full Title: A 6-MONTH, OPEN-LABEL, MULTI-CENTER, FLEXIBLE-DOSE EXTENSION STUDY TO THE B2061014 STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF DESVENLAFAXINE SUCCINATE SUSTAINED-RELEASE (DVS SR) TAB...
    Medical condition: Major Depressive Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-004264-23 Sponsor Protocol Number: GL61-001 Start Date*: 2006-01-31
    Sponsor Name:Gastrotech Pharma A/S
    Full Title: A randomized, double-blind, placebo controlled, cross-over, multi-center study to assess the effect of the GLP-1 analogue LY307161 in patients suffering from Irritable Bowel Disease
    Medical condition: Irritable Bowel Disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-002191-36 Sponsor Protocol Number: TAK-620-1019 Start Date*: 2022-07-18
    Sponsor Name:Shire
    Full Title: A Phase 1, Open-label, Randomized, Crossover, Bioavailability, Dose Proportionality, and Food Effect Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral...
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-023228-26 Sponsor Protocol Number: TZP-101-CL-P007 Start Date*: 2011-02-18
    Sponsor Name:Tranzyme, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastroin...
    Medical condition: post-operative ileus in subjects who have undergone partial bowel resection
    Disease: Version SOC Term Classification Code Term Level
    12.1 10054048 Postoperative ileus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) GB (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005208-14 Sponsor Protocol Number: R17548 Start Date*: 2012-06-18
    Sponsor Name:Norfolk and Norwich University Hospitals NHS Foundation Trust
    Full Title: Innovative Gel Aid for Administering Tablets to Stroke and Other Dysphagic Patients
    Medical condition: Healthy volunteers will be used in the study however the gel device being investigated has been developed with the aim of aiding swallowing in stroke and other dysphagic patients.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10013950 Dysphagia PT
    Population Age: Adults Gender: Male
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005058-27 Sponsor Protocol Number: 165-306 Start Date*: Information not available in EudraCT
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 3 Multi-Center Study to Evaluate the Safety and Efficacy of Subcutaneous Injections of Pegvaliase in Adolescent Subjects (Ages 12-17) with Phenylketonuria Featuring an Open-Label Randomized...
    Medical condition: Phenylketonuria (PKU)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10034873 Phenylketonuria (PKU) LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-001443-36 Sponsor Protocol Number: ARQ087-101 Start Date*: 2015-08-05
    Sponsor Name:ARQULE INC
    Full Title: A Phase 1/2 Study of ARQ 087 in Adult Subjects with Advanced Solid Tumors with FGFR Genetic Alterations, Including Intrahepatic Cholangiocarcinoma with FGFR2 Gene Fusion
    Medical condition: Advanced Solid Tumors with FGFR Genetic Alterations, Including Intrahepatic Cholangiocarcinoma with FGFR2 Gene Fusion
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10065143 Malignant solid tumour LLT
    20.0 100000004864 10073077 Intrahepatic cholangiocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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